UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026259 |
|---|---|
| Receipt number | R000029322 |
| Scientific Title | Phase II study for efficacy and safety of pembrolizumab for chemotherapy unfit previously untreated patients highly expressing PD-L1 positive advanced non-small cell lung cancer |
| Date of disclosure of the study information | 2017/03/27 |
| Last modified on | 2023/01/28 09:13:31 |
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Basic information
Public title
Phase II study for efficacy and safety of pembrolizumab for chemotherapy unfit previously untreated patients highly expressing PD-L1 positive advanced non-small cell lung cancer
Acronym
Phase II study of first-line pembrilizumab for advanced NSCLC patients with poor PS
Scientific Title
Phase II study for efficacy and safety of pembrolizumab for chemotherapy unfit previously untreated patients highly expressing PD-L1 positive advanced non-small cell lung cancer
Scientific Title:Acronym
Phase II study of first-line pembrilizumab for advanced NSCLC patients with poor PS
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To explore the efficacy and safety of pembrolizumab for high PD-L1 expressing advanced lung cancer patients who have no indication for standard chemotherapy, including cytotoxic chemotherapy and molecular targeted therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Progression-free survival, Overall survival, and Toxicity
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pembroliaumab 200mg/body (day 1, q3 weeks) until clinical progression or unacceptable toxicities
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Definitively diagnosed with having previously untreated advanced non-small cell lung cancer by the specimens histologically or cytologically who have no indication for standard treatment of chemotherapy including cytotoxic chemotherapy and molecular targeted agents for driver mutation. Also,
PD-L1 highly expressing NSCLC using PD-L1 IHC 22C3 pharmDx.
2) Age of 20 years and older
3) With adequate organ function of bone marrow reserve, liver, and kidney.
(1) PS 3-4
(2) neutrophil count => 5,000/mm^3
(3) platelet => 50,000/mm^3
(4) hemoglobin => 8.0g/dL
(5) AST/ALT < 5.0 times less than ULN
(6) T.Bil <= 3.0mg/dL
(7) serum creatinine <= 3.0mg/dL
(8) ECG: without clinically problematic abnormalities
(9) SpO2 more than 92%
4) With the status of below previous treatment at the time of beginning of chemotherapy.
(1) Radiotherapy: irradiated extrathoracic lesion: more than two weeks from the date of last irradiation
(2) Surgical procedure, including pleurodesis or pleural drainage
* more than 8 weeks with lobectomy
* more than 4 weeks without lobectomy, including exploratory thoracotomy
* more than 2 weeks after completing procedure (pleurodesis or pleural drainage)
5) With written informed consent
Key exclusion criteria
1) The age of less than 20
2) Indicative for cytotoxic chemotherapy or molecular targeted agents
3) Uncontrolled brain metastasis treated by palliative radiotherapy
4) Clinically active infection
5) Severe complication (cardiac diseases, interstitial pneumonia, uncontrolled hypertension or diabetes)
6) Uncontrolled pleural effusion
7) Active other organ cancers
8) History of severe drug allergy
9) Uncontrolled digestive ulcer
10) Any patients judged by the investigator to be unfit to participate in the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Hosomi |
Organization
Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital
Division name
Department of Respiratory Medicine and Thoracic Oncology
Zip code
113-8677
Address
3-18-22, Honkomagome, Bunkyo, Tokyo
TEL
03-3823-2101
yhosomi@cick.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Okuma |
Organization
Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital
Division name
Department of Respiratory Medicine and Thoracic Oncology
Zip code
113-8677
Address
3-18-22, Honkomagome, Bunkyo, Tokyo
TEL
03-3823-2101
Homepage URL
y-okuma@cick.jp
Sponsor or person
Institute
Department of Respiratory Medicine and Thoracic Oncology, Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Respiratory Medicine and Thoracic Oncology, Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Tokyo Metropolitan Komagome Hospital
Address
3-28-22, Honkomagome, Bunkyo, Tokyo
Tel
03-3823-2101
rinri@cick.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
がん・感染症センター都立駒込病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 03 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 21 | Day |
Last modified on
| 2023 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029322
